The following data is part of a premarket notification filed by Tyco Healthcare with the FDA for Monoject Insulin Syringe.
| Device ID | K033373 |
| 510k Number | K033373 |
| Device Name: | MONOJECT INSULIN SYRINGE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David Olson |
| Correspondent | David Olson TYCO HEALTHCARE 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-22 |
| Decision Date | 2003-11-13 |
| Summary: | summary |